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Health Tips / Anti-Doping: 2019 Guide for Prescribers

MEDICINES AND SPORT – Anti-Doping: 2019 Guide for Prescribers

The World Anti-Doping Code, published by the World Anti-Doping Agency (WADA), harmonises anti-doping regulations across all sports and in all countries. The Prohibited List of Substances and Methods is one of the International Standards that are mandatory for all signatories of the Code.

The List is a list of substances and methods which are prohibited in sport. Some of these substances are contained in medicinal products marketed in Ireland. However, in recognition of the fact that some prohibited substances may be necessary for legitimate medical treatment, the Code permits athletes and their physicians to apply for a Therapeutic Use Exemption (TUE).

Sport Ireland Therapeutic Use Exemption (TUE) Policy

If a medication is prohibited and requires a TUE, athletes should first seek to use an alternative permitted treatment. If there is no permitted alternative athletes should adhere to the Sport Ireland TUE Policy which states that athletes on the Sport Ireland Registered Testing Pool must apply for a TUE before using the substance (a Pre-Test TUE); athletes not on the Registered Testing Pool may take the substance, and if required, apply for a Post-Test TUE, but should ensure that a medical file* for use of the medication is in place. Athletes who compete at an International Level or who are on their International Federation Registered Testing Pool should check and comply with the TUE requirements of their International Federation.

Athletes should be advised to declare the use of all medications and supplements taken in the 7 days prior to the drug test on the doping control form (regardless if they have completed and submitted a TUE). Full details, TUE Application Form and guidelines on the TUE Policy are available at www.sportireland.ie/Anti-Doping/Athlete-Zone/Therapeutic-Use-Exemptions-/

S0 Non-Approved Substances: Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved for veterinary use only) is prohibited.

S2 Peptide Hormones, Growth Factors, Related Substances, and Mimetics: The following substances, including other substances with similar chemical structure or similar biological effect(s) and their respective releasing factors are prohibited:

S3 All Beta-2 Agonists are prohibited except: • Inhaled salbutamol (maximum 1600μg over 24 hours in divided doses, not to exceed 800μg over 12 hours, starting from any dose);

• Inhaled formoterol (maximum delivered dose of 54μg over 24 hours);

• Inhaled salmeterol (maximum dose of 200μg over 24 hours). To use any other inhaled beta-2 agonist, including terbutaline, indacaterol, vilanterol, olodaterol, formoterol (at delivered doses >54μg over 24 hours), salmeterol (at doses >200μg over 24 hours) and salbutamol (at doses >1600μg over 24 hours or >800μg over 12 hours; such as by nebuliser), an athlete must adhere to the TUE Policy paying particular attention to the requirements of a medical file*.

Formoterol is declared in terms of the delivered dose e.g. a Turbohaler device labelled as containing 6μg of formoterol delivers 4.5μg. Check the specific delivered dose of the device when calculating formoterol doses.

S5 Diuretics and Masking Agents: Diuretics (furosemide; spironolactone; thiazides, etc., including substances with a similar chemical or biological effect), desmopressin, probenecid, plasma expanders (e.g. IV administration of albumin, dextran, hydroxyethyl starch and mannitol, etc.), vaptans (e.g. tolvaptan) are prohibited. Note: Drosperinone, ophthalmic use of carbonic anhydrase inhibitors (e.g. dorzolamine, brinzolamide) and local administration of felypressin in dental anaesthesia are permitted. The detection in an Athlete’s Sample at all times or In-Competition, as applicable, of any quantity of the following substances subject to threshold limits: formoterol, salbutamol, cathine, ephedrine, methylephedrine and pseudoephedrine, in conjunction with a diuretic or masking agent, will be considered as an Adverse Analytical Finding unless the Athlete has an approved TUE for that substance in addition to the one granted for the diuretic or masking agent.

Prohibited Methods

M1 Manipulation of blood and blood components by (1) the administration or reintroduction of any quantity of autologous, allogenic (homologous) or heterologous blood or red blood cell products of any origin into the circulatory system, (2) the use of products that enhance the uptake, transport or delivery of oxygen e.g. modified haemoglobins, or (3) any form of intravascular manipulation of the blood or blood components by physical or chemical means is prohibited. Supplemental oxygen, by inhalation, is not prohibited.

M2 Chemical or physical manipulation such as tampering or attempting to tamper to alter the integrity and validity of a sample such as urine substitution and/or adulteration (e.g. use of proteases) is prohibited. IV infusions and/or injections of more than 100ml per 12-hour period are prohibited and require a TUE except for those legitimately received in the course of hospital treatments, surgical procedures or clinical diagnostic investigations. Emergency infusions will require a retroactive TUE.

S6 Stimulants including their related substances and their optical isomers are prohibited. Examples include amfetamine, lisdexamfetamine, modafinil and pseudoephedrine at urinary concentrations >150 μg/ml. Pseudoephedrine is found in many over the counter medicines available in pharmacies including many multi-ingredient products used as cough and cold remedies, hayfever and decongestant treatments. Athletes should stop taking any pseudoephedrine containing products at least 24 hours before competition.

For therapeutic applications during the in-competition period, athletes should consider the use of alternative permitted medications after prior consultation with their doctor or pharmacist, or apply for a TUE for the use of pseudoephedrine for therapeutic purpose(s). Local administration (e.g. nasal, ophthalmologic) of adrenaline or co-administration with local anaesthetic agents or the topical/ophthalmic administration of imidazole derivatives such as xylometazoline are not prohibited.

S8 Cannabinoids (natural and synthetic) and Cannabimimetics are prohibited except cannabidiol. Cannabidiol (available in Ireland as a food supplement; please see Sport Ireland’s Supplements and Sports Food Policy) when extracted from cannabis plants may potentially also contain varying concentrations of THC, which remains a prohibited substance.

S9 Glucocorticoids are prohibited and require a TUE when administered by oral, rectal, intravenous or intramuscular routes. Glucocorticoids administered by all other routes do not require a TUE.

This summary is deliberately concise and is intended to be used as a guide only. For an authoritative reference source consult the complete World Anti-Doping Code, The2019 Prohibited List and the International Standard for TUE (ISTUE) which are available from Sport Ireland or www.wada-ama. org. WADA have undertaken to update the Prohibited List regularly. All information correct at time of going to press.

Published December 2018

* Medical File: All Therapeutic Use Exemption (TUE) applications MUST be accompanied by a medical file reflecting current best medical practice to include:

1) A complete medical history

2) Copies of all relevant examinations and clinical notes (for example, if a clinic visit is referenced in a letter or summary, a copyof the clinical notes taken during the visit must be included)

5) A comprehensive report of the clinical examination with specificfocus on the respiratory system

6) A report of spirometry with the flow volume curve and the measure of the Forced Expiratory Volume in 1 second

7) If airway obstruction is present, the spirometry will be repeatedafter inhalation of a short acting β-2 agonist to demonstrate thereversibility of bronchoconstriction

8) In the absence of reversible airway obstruction, a bronchialprovocation test is required to establish the presence of airway hyperresponsiveness

9) If the athlete reapplies for a TUE that has expired, the application should include documentation that confirms the initial diagnosis as well as the reports and pulmonary function tests from regular asthma follow-up visits.